510(k) · Cleared
ClearedAquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, Inc. · FRO Dressing, Wound, Drug
Cleared on Jul 25, 2012 as substantially equivalent to K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) after an 89-day review. Its family tree reaches back 4 generations to 1992. 13 later devices descend from it.
- Decided
- Jul 25, 2012
- Review
- 89 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914604 (1992). 6 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 3 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 2 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 1 generation backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- This deviceK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK173675 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and…Convatec Limited · 2018
- Descendant · cites it directly · 2 of its ownK210718 LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver…Huizhou Foryou Medical Devices Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK172570 ALGS6 Ag Alginate Wound DressingFoshan United Medical Technologies, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK173844 Titan Ag 200Specialty Fibres and Materials, Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK252167 Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver…Qingdao Bright Moon Biomedical Materials Co., Ltd. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173675AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberConvatec Limited · 2018 · cites it directly4descendants
- K210718LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling…Huizhou Foryou Medical Devices Co., Ltd. · 2022 · cites it directly2descendants
- K172570ALGS6 Ag Alginate Wound DressingFoshan United Medical Technologies, Ltd. · 2018 · cites it directly2descendants
- K173844Titan Ag 200Specialty Fibres and Materials, Ltd. · 2018 · cites it directly1descendant
- K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber…Qingdao Bright Moon Biomedical Materials Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −3 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −2 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −1 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| 0 (this device) | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec, Inc. | 2012 | — |
| +1 | K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening… | Convatec Limited | 2018 | — |
| +1 | K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2022 | — |
| +1 | K172570 | ALGS6 Ag Alginate Wound Dressing | Foshan United Medical Technologies, Ltd. | 2018 | — |
| +1 | K173844 | Titan Ag 200 | Specialty Fibres and Materials, Ltd. | 2018 | — |
| +2 | K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling… | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingSummary page 1…ssing, Wound, Drug Device Class: Unclassified Product Code: FRO Predicate Device: AQUACELWm Ag Hydrofiber TM Dressing, K080383 AQUACEL Tm Ag EXTRA TM Hydrofiber Tm Dressing with Silver and Strengthening Fiber isa one piece wound dressing comprised of two… | 2008 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber | 2018 | 4 |
| K210718 | LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling… | 2022 | 2 |
| K172570 | ALGS6 Ag Alginate Wound Dressing | 2018 | 2 |
| K173844 | Titan Ag 200 | 2018 | 1 |
| K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200… | 2024 | 0 |
| K160379 | Exufiber Ag+ | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K173675 (Convatec Limited, 2018) has gone furthest, with 4 descendants of its own.
- 14 other devices also cite its predicate K080383.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
For Over-the-Counter Use: AQUACEL Ag EXTRA Hydrofiber Dressing with Silver and Strengthening Fiber may be used for: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional: AQUACEL Ag EXTRA Hydrofiber Dressing with Silver and Strengthening Fiber may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; - Partial…
Read the full statement (179 words)
For Over-the-Counter Use:
AQUACEL Ag EXTRA Hydrofiber Dressing with Silver and Strengthening Fiber may be used for:
- Abrasions
- Lacerations
- Minor cuts
- Minor scalds and burns
Under the supervision of a healthcare professional:
AQUACEL Ag EXTRA Hydrofiber Dressing with Silver and Strengthening Fiber may be used for the management of:
- Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection;
- Partial thickness (second degree) burns;
- Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
- Surgical wounds left to heal by secondary intention such as dlehisced surgical incisions;
- Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g. orthopedic and vascular);
- Traumatic wounds;
- Wounds that are prone to bleeding, such as wounds that have been mechanically or surgicaliy debrided and donor sites;
- Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma;
- Painful wounds;
- Infected wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121275: Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121275
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026